What is the standard of GMP medical device workshop
Wind speed Air volume number of air changes Unidirectional flow/non-unidirectional flow Temperature and humidity Differential pressure Suspended particles Plankton Sedimentation bacteria noise intensity of illumination Firstly, the term GMP originated from the pharmaceutical industry, and was later borrowed by the medical device industry. The medical device production quality management Standard and its appendix stipulate and require medical device manufacturers to establish and improve the quality management system in accordance with relevant regulations. The contents include organization and personnel, plant and facilities, equipment, document management, design and development, procurement, production management, …
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